Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

Binge-Eating Disorder Clinical Trial

Official title:

Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03539900
• Other study ID #: 2000021769
• Secondary ID: R01DK112771
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 17, 2018
• Est. completion date: March 22, 2023

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity.

Description:

Binge-eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with BED are needed that can produce sustained clinical outcomes. This study aims to test the efficacy of Naltrexone/Bupropion (NB; FDA-approved anti-obesity combination medication) for the treatment of BED in patients with and without obesity. The RCT will provide new findings regarding the efficacy of NB medication for reducing binge-eating episodes among patients with BED, for reducing weight among patients with BED and obesity, and whether patients with and without obesity derive differential benefit from NB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: March 22, 2023
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition);

• BMI in the obesity (BMI >30 and <50) or non-obesity (BMI >21.5 and <29.9) range;

• Available for the duration of the treatment and follow-up (15 months);

• Read, comprehend, and write English at a sufficient level to complete study-related materials.

Exclusion Criteria:

• Currently taking opioid pain medications or drugs; or positive drug screen for opiates

• Currently taking medications that influence eating/weight;

• History of seizures;

• Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality);

• Past or current anorexia nervosa or bulimia nervosa;

• Pregnant or breastfeeding;

• Medical status judged by study physician as contraindication.

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Drug:
• Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.

Other:
• Placebo
Placebo will be inactive and taken daily in pill form.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Binge Eating Frequency	Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment."	Post-treatment (3 months)
Primary	Percent BMI Change	BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at posttreatment] - [BMI at baseline])/[BMI at baseline]. Negative values indicate loss.	Post-treatment (3 months)
Secondary	Change in Binge Eating Frequency	Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 6 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 6 months post-treatment.	6 months post-treatment
Secondary	Change in Binge Eating Frequency	Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 12 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 12 months post-treatment.	12 months post-treatment
Secondary	Body Mass Index	BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at 6 month followup] - [BMI at posttreatment])/[BMI at posttreatment]. Negative values indicate loss.	6 months post-treatment
Secondary	Body Mass Index	BMI was calculated using measured height and weight. We report percent BMI change using the following formula: ([BMI at 12 month followup] - [BMI at posttreatment])/[BMI at posttreatment]. Negative values indicate loss.	12 months post-treatment